According to known prior art, intraocular lens (IOLs) are selected and adjusted based on the measured and/or estimated measurements, wherein only individual parameters in the form of individual measurement values or as a mean value over specified patient groups are taken into consideration.
In this regard, the selection and adjustment of the optimal IOL takes place solely according their features, such as type, refractive power, asphericity, and multifocality. Taking into account possible dependencies on specific accompanying circumstances of the treatment, such as characteristics of the patients, diagnoses, surgical procedures, and similar, occurs just as infrequently as the use of statistical distribution for the parameters.
Selecting the suitable intraocular lens for a patient is the responsibility of the cataract surgeon. In this regard, the surgeon must take into consideration many factors. First, depending on the individual biometric parameters of the eye, the suitable calculation method of the IOL refractive power should be selected. To do so, generally for extraordinarily long, normal, or extraordinarily short eyes, various more or less suited formulas are used for calculation purposes. In the simplest situation, their input parameters are based on keratometry and axis lengths of the eye, wherein the formulas, due to their simplified model assumptions, also contain an empirically determined correction factor, such as the so-called A constant, for example.
The currently most widespread calculation methods are the so-called IOL formulas, e.g., according to Haigis, Holladay, Hoffer, Olsen, Shammas, or SRK. Accordingly, refraction D (output/evaluation parameter) of the patient is calculated after inserting the IOL byD=DIOL−f(K,AL,VKT,A)  (1)wherein f( ) is a conventionally known IOL formula
DIOL is the refractive power of the IOL,
K is the measured keratometry value,
AL is the measured axis length of the eye,
VKT is the measured depth of the anterior chamber and
A is an IOL-type-dependent constant input value.
The various calculation methods (biometry formulas) generally use various IOL-type-dependent constants (i.e., IOL constants). An A constant is used in the SRK formula for example.
For selecting the IOL, the physician sets a target refraction (D=Dtarget). For optimization purposes, the physician calculates the refraction (1) according to various IOLs by varying DIOL and A. In many cases, the physician uses IOLs of the same type, so that no variation in A results, and the optimization boils down to a formula calculation according to DIOL=Dtarget+f(K, AL, VKT, A). If emmetropia is the objective, this results in the traditional formula calculation of the IOL according to DIOL=f(K, AL, VKT, A).
The constant A in the formulas is determined empirically via a patient group to adapt the formula values to the actually resulting optimal refraction values. However, this adaptation only ensures that the mean value of the refraction values agrees with the formula over the test group.
To minimize systematic errors, currently other approaches are being selected according to prior art.
For example, a series of physicians uses a different A constant for each ethnic group among their patients. In this way, errors can be systematically reduced and, to the extent the statistical scatter in the respective group is lower, so can the statistical errors.
Depending on specified starting conditions, such as patients with long axis lengths or with prior refractive corneal surgery, other physicians use various biometry formulas that are better adapted to the respective requirements, or that presuppose the measurement of additional parameters, such as anterior chamber depths or lens thickness. Here, too, systematic errors in particular are decreased, wherein however, the statistical errors can increase partially due to the additionally measured parameters.
Presupposing or predicting the postoperative position i.e., the “effective” orientation of the implanted intraocular lens in the eye, plays a major role. Various formulas pertain to determining the postoperative ELP of various assumptions, based on diverse biometric parameters of the eye. In the simplest case, these are: keratometry and axis length of the eye. Fourth-generation formulas, as they are called, use up to six parameters for predicting the ELP, such as: axis length, anterior chamber depth, keratometry, lens thickness, limbus diameter, and age of the patient. Due to the simplified model assumptions of the eye, as well as the “empirical” nature of the many formulas, i.e., optimization of the formula results via constants, “virtual” values result for the calculated ELP, so that the ELP required for an optimized result does not generally correspond to the actual anatomical lens position in the eye. The reason for this is that due to the postoperative refraction results and the resulting average error correction (e.g., through the A constant), only the predicted ELP can change because all other parameters were measured. Optimization via constants does not take into account that other preoperatively measured parameters could have changed postoperatively in addition to the expected refraction result.
Another method to predict the ELP is based on the principle of determining the capsular bag equator and is described in U.S. Pat. No. 5,968,095 A. In doing so, the distance of the lens haptic to the anterior surface of individual IOL designs is taken into account. The orientation of the capsular bag equator can thus be determined in various ways. With this method, one can theoretically achieve a prediction of the ELP that is independent of the individual IOL design.
In contrast to the postoperative effective lens position (ELP), which due to the simplified model assumption of the eye as well as empirical formulas does not generally correspond to the actual anatomical lens position, the anatomical postoperative lens position defines the actual, i.e., real, postoperative position of the intraocular lens to be implanted.
The term “haptic” refers to the support structure existing for fixing the intraocular lens in the eye. The haptics are arranged peripherally to the actual optic lens and may be constructed in various shapes, such as brackets, plates, or straps.
In the known IOL design-dependent or independent methods according to prior art for predicting or determining the postoperative ELP, a disadvantageous effect is that none of the known methods can do without empirical correction factors. One reason for this are individual postoperative healing processes that usually last over a period of several weeks, which is not taken into account in the methods known to date. Another reason may be seen in that despite diverse methods, only an insufficient number of parameters relevant for determining the ELP is taken into account in the prediction.
Another problem lies in the optimization method of the formula approaches. Improving the postoperative refraction results by application of the constant procedure takes into consideration all errors occurring in cataract surgery. These are errors in the measurement procedures, errors in the IOL calculation, and unexpected events during the implantation and healing processes. However, optimizing the results solely by use of postoperative refraction excludes individual error sources from being taken into account.